Startups & SMEs
Spain has one of the highest incarceration rates in Europe, with 160 individuals imprisoned per 100,000 residents. In 2020, 43,494 people were incarcerated in facilities not managed by regional health authorities — essentially all regions except Catalonia, the Basque Country, and Navarra.
The Acton, MA-based tubeless insulin pump specialist expands its indication for the Omnipod 5 AID system beyond type 1 diabetes as FDA authorization for type 2 comes sooner than Wall Street expected. Analysts expect clearances of rival systems from Tandem Diabetes Care and Medtronic in 2025, but believe Insulet is well-positioned to compete.
Two years after the EU adopted the original common specifications for certain products under the IVD Regulation, the commission has added new products and updated its requirements.
Hello Heart has introduced a symptom tracking feature in its app, allowing users to log feelings of dizziness or shortness of breath in conjunction with blood pressure readings. The enhancement will help all users to monitor cardiovascular risks, but women in particular could benefit, the company suggests.
The Seattle-WA-based company’s latest capital raise follows study results published in July in which Know Labs’ proprietary non-invasive RF dielectric sensor and machine learning algorithms correctly classified participants’ glycemic status as hyperglycemic, normoglycemic, or hypoglycemic with 93.37% accuracy compared with venous blood glucose values. Know Labs' goal is to commercialize a diabetes screening device that could help to funnel undiagnosed patients into the health care system.
Global investment firm Carlyle has agreed to pay $3.8b for Baxter International’s Kidney Care unit. The newly spun-off business will be known as Vantive.
TRiCares SAS announced it raised $50m in series D funding from a single unnamed investor. The funding will support the company’s upcoming US early feasibility study and EU CE mark clinical investigation for its transfemoral tricuspid heart valve replacement system, Topaz.
UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.
Swiss-based start-up DeepPsy aims to streamline mental health care using EEG and ECG biomarkers to better match depression patients with treatments. Co-founder Mateo de Bardeci discusses the company’s vision as it launches its in-house medical device as a service in Switzerland.
The Innovative Device Access Pathway pilot has launched in the UK with eight new promising medical technologies. The cohort is overwhelmingly diagnostic-focused, with innovative testing for Alzheimer’s, stroke, and liver cancer, amongst others.
Three UK medtech companies’ views on how their businesses will be influenced by external factors in the coming year.
Biobeat defies the usual trend of start-ups seeking ever-growing sums of capital before either going public or being acquired. Its CEO, Arik Ben Ishay, believes the company can quickly become self-sufficient by tackling endemic problems.
“There’s no one company, government, person or technology who is positioned to ‘solve’ the health of the world,” notes Haleon's Nick Tate. Which is why OTC companies are partnering with tech firms large and small to create the next generation of consumer healthcare products and services. In the first part of an exclusive interview on the future of digital consumer health, Tate – who heads up the firm’s incubator business, Haleon NEXT – discusses some of the complications of tech innovation that make such collaboration attractive.
The EU Innovative Health Initiative has opened its doors to a new round of applicants, with opportunities for the medtech sector to form research groups with other stakeholders and work on projects including novel diagnostics and digital mental health tools.
Marc-Pierre Möll, CEO of German medtech-industry association BVMed, is hoping for a more collaborative year in 2023 after the health ministry came out with proposals to change the DRGs system and the EU finally conceded that its unhelpful MDR timetable was riding roughshod over the wellbeing of patients.
Spectaris’ Marcus Kuhlmann describes Medica as a valued hub to meet member companies and host ecosystem and trade updates for the wider medtech industry. The German industry association’s medtech leader spoke to Medtech Insight during the 2022 event about the top concerns for manufacturers.
The Medtronic Neurovascular Co-Lab Platform is an “always on” online portal that will help Medtronic identify and work with developers of new technologies to prevent and treat strokes, a major cause of death and disability that is rarely treated effectively.
Is regulating artificial intelligence a good idea? A lawyer questions whether the European Commission’s proposed AI Act is appropriate for medtech, where a growing “regulatory lasagna” could compound notified body capacity issues and SME workload.
Sparta Biomedical is developing a synthetic cartilage-on-titanium knee implant based on its proprietary Galene process for infusing cellulose fibers with polyvinyl alcohol. The company hopes to begin clinical trials in 2023.
Congress extended the Small Business Innovation Research and Small Business Technology Transfer programs, right before they were set to expire on 30 September.